drugset / Trial / NCT07428538
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score greater than or equal to (\>=) 32 and Model for End-stage Liver Disease (MELD) scores 21-30, inclusive.
Timeline
- Start
- 2026-01-29
- Primary completion
- 2027-11
- Completion
- 2028-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Larsucosterol | Small molecule | 30 mg | Intravenous |